The present invention relates to externally worn restraint devices for the upper torso including the arm, wrist and shoulder of a human patient, particularly as such devices are used to restrict or restrain arm and shoulder movement after pacemaker or ICD (implantable cardiac defibrillator) implant surgery.
Pacemakers and ICD's are small devices implanted usually below the left or right clavicle/collar bone. They are usually placed in a formed pocket subcutaneous (below the skin). Wire leads are connected to the implanted device and placed inside the heart through appropriate blood vessels. Multiple leads can be placed in the left ventricle, right ventricle, and right atrium. The collection of leads and the implanted device form a system, which is sutured to the skin in the pocket at an access point below the left or right clavicle. It is very important that the system remain stable during healing time, which typically lasts anywhere from up to 6 weeks.
It is crucial to patient recovery for the system to remain stable during this healing time to prevent lead dislodgment. Most lead dislodgements occur before 3 weeks, but can occur months later. If a lead is pulled out, this causes major complications whereas a revisit to the OR/Cath Lab is required and the lead is reset and repositioned. The patient then faces an increased chance of infection. It is noted that each time a patient undergoes surgery for a battery generator change or a lead reposition, there is a 3% increase in chance of infection. This is also very costly to the patient and the hospital, requiring another overnight stay and more medication for the additional procedure.
To reduce the potential of dislodgement, some physicians leave a little extra wire in the heart. However, this may lead to other complications including valve dysfunction and pro arrthymic conditions.
Some physicians prescribe external restraint devices. These devices are designed to restrict movement of the patient's arm and shoulder relative to the torso. Routinely used is an arm sling to immobilize the shoulder. Arm slings are extensively used to protect and/or support an arm following an injury or sickness and a variety of arm slings are well known. For example, U.S. Pat. No. 6,770,044 issued to Joslin on 3 Aug. 2004 is characteristic of such slings that form a pouch into which the forearm can be placed, allowing the hand to partially or fully extend from the front end of the pouch and provides a cradle or pocket to rest the elbow. A strap secures to the pouch and is slung over the wearer's neck and shoulder to support the sling in relative vertical position relative to the wearer's torso. However, horizontal (away from the torso) movement is not restricted except by the practical physical limitations of the strap. Thus, when such a typical sling is used post implant surgery, there is inadequate restriction of movement and the lead wires can become dislodged. With a traditional shoulder sling, there is also the very real chance of “muscular atrophy” and “frozen shoulder”.
Another attempt to reduce arm movement includes the apparatus disclosed by Vanderpool in U.S. Pat. App. No. 2008/0029104A1 published on 7 Feb. 2008. The Vanderpool apparatus includes several stout rubber bands linked together. One end of the linked bands attaches to a belt worn about the waist of the patient, and the other end attaches to the wrist of the restrained arm of the patient. Thus, by varying the length of the rubber bands linked together, the range of motion of the restrained arm can be limited relative to the torso. However, the Vanderpool device does not contemplate restricting movement of the shoulder or upper arm.
Yet another known restraining device includes the arm sling apparatus allowing movement or total immobilization disclosed by Jestrabek-Hart in U.S. Pat. No. 6,979,303 issued on 27 Dec. 2005. The Jestrabek-Hart apparatus includes a cooperating suspension system and support frame to transfer the weight of the arm to the torso allowing the shoulder to rest. The suspension system includes one or more suspending devices engages and supports the arm with a rigid support frame consisting of a stiff waist belt and rigid upright support arm. Immobilization straps adjust to permit varying degrees of immobility. However, the Jestrabek-Hard apparatus does not contemplate restricting movement to maintain leads from an implanted device and is of such complexity that it precludes the patient from self-adjusting, and precludes the patient from putting this apparatus on without assistance from a care giver. Moreover, the Jestrabek-Hard apparatus is costly to own and operate.
Kirkpatrick et al. in U.S. Pat. No. 6,095,936 issued on 1 Aug. 2000, teach an arm restrain apparatus for aiding basketball players, the apparatus comprising a first engaging member being attached to a waist, a second engaging member being attached to a forearm, and a flexible or resilient band interposed there-between, the resilient band being of a length sufficient to reduce or prevent movement of the arm above shoulder height. However, Kirkpatrick et al. expressly teach away from a device suitable for use to restrict arm movement to prevent lead displacement post-operatively—for instance, in FIGS. 5, 6 and 7, Kirkpatrick et al. illustrates moving the arm above the head—this could result in lead displacement.
Another shortcoming not contemplated in the present art is a lack of a sensor to detect excess movement and no warning device to alert the patient and or medical staff that the arm is about to move beyond a safe range in the restricted range of movement of the wearer.
Thus, there remains a need for a device that can easily be worn by a patient after implant surgery. The device should enable the recovering implant patient to put on or take off the device without any assistance of a caregiver or other person. Further, such an improved device should overcome the disadvantages known in the prior- and current-art. The device should enable the patient some movement of the arm and shoulder but still prevent the lead wires from moving inside the body. Additionally, the improved device should prevent patients from raising their shoulder and pulling/tearing the lead tip from the endocardium. And, such an improved device should discourage movement of the upper arm and shoulder, and wrist relative to the torso.